Engineer III - Downstream, Viral Vector Product Development

Engineer III - Downstream, Viral Vector Product Development

This is what you will do :

The candidate contributes to the Viral Vector Process Development group through the design and execution of experiments based around downstream AAV (Adeno-Associated Virus) manufacturing processes.

They will act as a purificaiton SME to generate, interpret, and present experimental data to inform and recommend operating process operating conditions with the goal of developing a robust and scalable manufacturing process.

They will additionally draft documentation and provide expertise to assists in scale-up and tech transfer to clinical / commercial manufacturing facilities as well as submission of regulatory filings.

You will be responsible for :

• Perform early and late phase process development and optimization of AAV purification process steps (chromatography, filtration, UF / DF)
• Lead the design and execution of OFAT and DoE-directed experiments to identify key and critical process parameters and to identify and recommend acceptable ranges for process scale-up large-scale manufacturing
• Document experiments, compile analytical data, and summarize findings in lab notebook entries and reports to facilitate scale up and tech transfer activities.
• Coordinate with process analytics and method development team to align sample submission requests and process workflows
• Support tech-transfer of manufacturing processes to external partners. At times provide person-in-plant (PIP) support to ensure successful operation
• Author development reports, tech transfer documents, and other relevant process / regulatory documents for pipeline programs and research collaborations
• Engage in platform development for the evaluation and implementation of novel technologies to improve purification efficiency and product quality
• Contribute to CMC program teams, providing updates and ensuring process development milestones and requirements are met

You will need to have :

• BS or MS degree in Chemical Engineering, Biochemistry, or related discipline w / 5+ years (BS) or 3+ years (MS) of relevant experience in the biotech industry
• Experience developing biologics purification process steps (Clarification, chromatography, UF / DF, NFF)
• Experience with statistical analysis and design of experiment (DOE) using software tools such as JMP
• Experience drafting process development reports, tech transfer documents, and other relevant process / regulatory documents
• The duties of this role are generally conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to : lift / carry 15 / 30 pounds unassisted / assisted;
• work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown / degown PPE;
• use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue;

collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have :

• Experience developing AAV specific purification processes (Clarification, NFF, chromatography, UF / DF)
• Experience developing high-throughput purification screening techniques with liquid handlers or other tools
• Experience or understanding of molecular or physical biology analytical techniques (qPCR, ELISA, HPLC)

Date Posted

14-May-2024

Closing Date

30-Dec-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.

The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.

Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.